VP Head of Regulatory Affairs and Pharmacovigilance
6 days ago
About the Role
Merus Netherlands is seeking an experienced and innovative leader to join our team as the Vice President, Head of Regulatory Affairs and Pharmacovigilance. This pivotal role is responsible for ensuring the company remains a leader in patient safety and pharmacovigilance, fostering a culture where safety is integrated into every aspect of our drug development process.
Key Responsibilities
- Lead and build Merus's Regulatory Affairs and Pharmacovigilance function, ensuring compliance with global regulatory standards.
- Establish and maintain a safety and pharmacovigilance infrastructure that prioritizes 'safety by design' in all development activities.
- Lead all pharmacovigilance and risk management activities for Merus products, including safety surveillance, signal detection, and risk-benefit assessments.
- Serve as the primary contact for safety-related issues, including regulatory authority interactions and safety service provider management.
- Provide strategic safety insights to the Chief Medical Officer and Executive Leadership Team, particularly regarding the risk-benefit profile of company products.
- Oversee the preparation and review of safety documents, including DSURs, safety reports, and clinical development documentation.
- Ensure compliance with global safety regulations and guidelines, and lead responses to safety-related inquiries from regulatory authorities.
- Manage the pharmacovigilance budget and resources, including both internal teams and external contractors.
- Drive continuous improvement in pharmacovigilance practices, ensuring readiness for regulatory inspections and audits.
- Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Quality, to integrate safety considerations into company strategy.
- Represent Merus externally, building relationships with industry leaders and vendors to enhance our safety and pharmacovigilance capabilities.
Requirements
- Minimum of 10 years of global experience in drug safety within the biotechnology or pharmaceutical industry.
- In-depth knowledge of FDA safety regulations, ICH Guidelines, EU GVP, and other global safety regulations.
- Deep understanding of risks and risk mitigation steps related to safety signals and pharmacovigilance.
- Expert knowledge of safety database applications (e.g., ARGUS, ARISg) and safety signal detection.
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